Manufacturer

Biodetect

ChinaLegal entities : BioDetect（Xiamen）Biotechnology Co., Ltd.

Markets : Austria · Netherlands · Poland

EU representative : SUNGO Europe B.V. (Netherlands)

3 categories, 18 models including 18 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Viral antigen/antibody detection - other	W0105040699	MPX0020198/79 MPX0020598/79 Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold) MPX0010198/79 Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold) MPX0010598/79 Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold) MPX0012098/79 10 others Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold) MPX0022098/79 Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold) MPX0030198/79 Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold) MPX0030598/79 Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold) MPX0032098/79 Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold) MPX0040198/79 Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold) MPX0040598/79 Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold) MPX0042098/79 Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold) MPX0050198/79 Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold) MPX0050598/79 Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold) MPX0052098/79	– 98/79	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	2019-nCoV Molecular Diagnostic Kit(Fluorescent PCR Test)98/79 Monkeypox Virus Molecular Diagnostic Kit (Fluorescent PCR Test) (Lyophilized)98/79	– 98/79	EUDAMED record Report an error
Virology - RT & POC - other	W0105099099	Rapid SARS-CoV-2 Antigen Test Card3 refs98/79	– 98/79	EUDAMED record Report an error

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